Negara: Australia
Bahasa: Inggris
Sumber: Department of Health (Therapeutic Goods Administration)
olmesartan medoxomil, Quantity: 40 mg; amlodipine besilate, Quantity: 6.935 mg (Equivalent: amlodipine, Qty 5 mg)
Arrotex Pharmaceuticals Pty Ltd
Tablet, film coated
Excipient Ingredients: magnesium stearate; croscarmellose sodium; colloidal anhydrous silica; pregelatinised maize starch; silicified microcrystalline cellulose; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350
Oral
10 tablets, 30 tablets
(S4) Prescription Only Medicine
It is indicated for the treatment of hypertension. Treatment should not be initiated with this fixed-dose combination (see Dosage and Administration).
Visual Identification: Light yellow, round, biconvex, film-coated tablets debossed with L77 on one side and plain on other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2018-06-13
OLMESARTAN/AMLODIPINE APOTEX 1 OLMESARTAN/ AMLODIPINE APOTEX _Olmesartan medoxomil and amlodipine besilate _ CONSUMER MEDICINE INFORMATION FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Olmesartan/Amlodipine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using Olmesartan/Amlodipine against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT THIS MEDICINE IS USED FOR Olmesartan/Amlodipine is used to treat high blood pressure which is sometimes called hypertension. Everyone has blood pressure. This pressure helps push blood all around your body. Your blood pressure changes at different times of the day, depending on how busy or worried you are. You have hypertension (high blood pressure) when your blood pressure stays higher than is needed, even when you are calm and relaxed. There are usually no symptoms of hypertension. The only way of knowing that you have hypertension is to have your blood pressure checked on a regular basis. If high blood pressure is not treated it can lead to serious health problems, including stroke, heart disease and kidney failure. Olmesartan/Amlodipine contains olmesartan medoxomil, which belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which causes blood vessels to tighten. Olmesartan/Amlodipine blocks the action of angiotensin-II and therefore relaxes your blood vessels. This helps lower your blood pressure. Olmesartan/Amlodipine also contains amlodipine besilate, a calcium channel blocker. This reduces the movement of calcium into the cells of the heart and blood vessels. This also helps to lower blood pressure as it relaxes the bl Baca dokumen lengkapnya
AUSTRALIAN PRODUCT INFORMATION – OLMESARTAN/AMLODIPINE APOTEX tablets (Olmesartan medoxomil/ amlodipine besilate) NAME OF THE MEDICINE Olmesartan medoxomil and amlodipine besilate QUALITATIVE AND QUANTITATIVE COMPOSITION OLMESARTAN/AMLODIPINE 20/5 APOTEX tablets contain 20 mg olmesartan medoxomil and 5 mg amlodipine (as besilate). OLMESARTAN/AMLODIPINE 20/10 APOTEX tablets contain 20 mg olmesartan medoxomil and 10 mg amlodipine (as besilate). OLMESARTAN/AMLODIPINE 40/5 APOTEX tablets contain 40 mg olmesartan medoxomil and 5 mg amlodipine (as besilate). OLMESARTAN/AMLODIPINE 40/10 APOTEX tablets contain 40 mg olmesartan medoxomil and 10 mg amlodipine (as besilate). The tablets contain no excipients with a known effect. For the full list of excipients, see Section 6.1 List of excipients. PHARMACEUTICAL FORM OLMESARTAN/AMLODIPINE 20/5 APOTEX - white, round, biconvex, film-coated tablets debossed with “L75” on one side and plain on other side. OLMESARTAN/AMLODIPINE 20/10 APOTEX - greyish-orange, round, biconvex, film- coated tablets debossed with “L76” on one side and plain on other side. OLMESARTAN/AMLODIPINE 40/5 APOTEX - light yellow, round, biconvex, film-coated tablets debossed with “L77” on one side and plain on other side. OLMESARTAN/AMLODIPINE 40/10 APOTEX - red (brownish red), round, biconvex, film-coated tablets debossed with “L78” on one side and plain on other side. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS OLMESARTAN/AMLODIPINE APOTEX is indicated for the treatment of hypertension. Treatment should not be initiated with this fixed-dose combination (see 4.2 Dose and Method of Administration). 4.2 DOSE AND METHOD OF ADMINISTRATION OLMESARTAN/AMLODIPINE APOTEX is registered in four strengths: OLMESARTAN/AMLODIPINE 20/5 APOTEX (olmesartan medoxomil 20 mg and amlodipine as besilate 5 mg); OLMESARTAN/AMLODIPINE 20/10 APOTEX (olmesartan medoxomil 20 mg and amlodipine as besilate 10 mg); OLMESARTAN/AMLODIPINE 40/5 APOTEX (olmesartan medoxomil 40 mg and amlodipine as besilate 5 mg); OLMES Baca dokumen lengkapnya